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at a conference on counterfeit prescription drugs. she discussed the new fda initiative to educate consumers, called bsafe our ex. this conference was hosted by the partnership for safe medicine. the fda commissioner's remarks are 20 minutes. >> thank you. it's really a pleasure to be here once again with the partnership for safe medicines. this is a really important topic to me personally and professionally, and really given our shared shared commitment to make our nation drug supply safe, effective, secure and high quality as possible, the work with a partnership is very, very meaningful to us. they have been an important and reliable ally for fda, and we so value the work of the partnership. given the enormity of the challenge in front of us to protect the american people from contaminated counterfeit, substandard and other unsafe drugs at a time when the marketplace is global, when the speed of communications is near instantaneous and the money to be made through deception and fraud, it seems almost -- almost limitless. our goal is to make our already strong partnership even stronger and
an improvement. when the fda aproves a drug for marketing, a new drug, what the manufacturer has to establish is that the new drug is better than nothing. >> are we talking about wikperdol? >> that's one of the drugs. this is a whole category but that's the one in the study. if you found this is true, the newer drug will claim it's an improvement or suggested an improvement, plus the impact of the advertising programs and the solicitation of doctors from brands? i don't want to -- we're not here to fault brand drugs and we'll explain that in a minute. but, there is no advertising for the drugs that we're talking about here. the generic drugs. >> very little promotion of generic drugs to consumers or doctors. >> because when the brand drugs goes off patent, you get a variety of generic companies. it's per missibility and for all genarks to enter the competition, correct? >> for the first 6 months, the first generic manufacturer to challenge the patent has exclusivity for 6 months. this is very important because this was created by the hatch wax man act in 1984. and it creates a 6 month exexclu
. >>> coming up, check this spec. with 25 drugs in development, and a major fda advisory panel meeting next week, cramer is examining a stock that could be the next big thing in biotech. stick around. you can't afford to miss his prognosis. >>> and later, hot to trot? all this week, cramer's finding the stocks that the big money is most likely buying hand over fist and should continue to rise until year end. tonight, the temperature reaches a featured pitch as he adds two biotech behemoths to his hot list. don't move, the big reveal is just ahead. >>> plus, "mad money" at the movies." cramer has a theatrical flare. tonight, he shares the screen with the baddest cast member of "argo." don't miss cramer and cranston on one screen. all coming up on "mad money." >>> don't miss a second of "mad money" follow @jimcramer on twitter. #madtweets. send an e-mail to madmoney@cnbc.com or call 1-800-743-cnbc. >>> miss something? head to madmoney.cnbc.com. >>> different strokes here. want to be a good investor, you need to understand that managing your money requires more than simply able to be able to c
defense council to ban it, saying more studies were needed. the fda declined an interview with to the contrary but released the following statement. "fda is constantly monitoring the science on the substances or products it regulates, including bpa. fda's strategy to address concerns about bpa is founded on science; we have invested significant resources to research and review any and all scientific findings." >> the fda, the food and drug administration, can regulate chemicals that can get into our food. bisphenol a isn't only going into our food, in fact it's not considered a direct food additive. it's an indirect food additive, in that it makes its way into the food by leeching out of the containers that come in contact with the food. and so the legislative authority isn't straight forward. >> as an indirect additive the fda is limited in its ability to regulate bpa. bpa is protected by its use in interstate commerce, making it difficult for the fda to restrict use. >> there is a lot of push-back from the chemical industry from the companies that are making these produc
.anais gessler explains... the f-d-a is now investigating a weedy crrssland, mothhr: (wttg))""t's just ommthing yyu nnver wanna go throuuh." wendy crossland is coming up on the one- year anniversary of losing her daughter, anaiss wendy crrsssand, mother: (wttg) "she was gasping for air. she waa making thesee awful noises. she had no &ppulse, but her heart was stii and her eart had stopped and started cpr."the 14- yeer- old haaerstown girl was rushed to johns hopkins hospital, but later died.tteecause of death: cardiac arrhythmia due to caffeine toxicity.her mother says monster energy drinks led gimbel,,substance aause mike educator: 1.40 they can put away one of these cans in a couple of minutes, so it becomes very, very dangeeouu. and, it's been that way for a whhle."drug czar mike gimbel urres warning labels or even age limits on energy drinkss mike gimbel, substance abuse educatoo: 3.44 "many of these kids are drinking tteee every day."paul gessler, reporter: "advocates say the problem has grown over the years... literaaly. thhs is monster energg's single serve ddink. this is what anais d
not by the fda.gulated that, her family says, is unacceptable. >> december 2011. the girl was just 14 years old. the family blames it on the drinks she drank than 24 hours. they filed a wrongful death against the california that makes the drink. >> caffeine toxicity and a contract arrhythmia. she had an underlying mild heart condition not unlike about 10% of the population. fda documents show other adverse reactions to the drink. >> these kids are drinking the , have an condition, it is like on a fire.oline spokesman for the beverage company says it has sold more than 8 billion of the drinks " monster does that its beverages are in any way responsible for death of ms. fournier." on the anderson cooper show last week, the mother says she is putting her grief into action. the fda too put stepup. [indiscernible] how much caffeine is in there. >> that mom has made some progress. the senator who oversees the fda budget held a hearing on the drinks and their impact on kids. he has sent a second letter to a asking that agency to regulate the drink. >> thank you for that report. countdown to the electi
the extent to which these claims are truthful and not misleading. because f.d.a. doesn't have the ability to look at the substantiation behind the claims, there's really no way for them or consumers to know whether or not the claims are truthful. >> reporter: the f.d.a. has only limited power to regulate supplements because federal law classifies them as food not drugs. products are required to be safe but the f.d.a. only monitors them after they're on the market. when it comes to proof, supplement makers are only required to say research has been done, they are not required to show it to the f.d.a. the natural products association-- the main trade group of the supplement industry-- issued a statement saying: the investigators looked at 127 supplements that claim to boost the immune system or help with weight loss. none-- none-- met all of the f.d.a.'s recommendations for proving the products actually work. >> pelley: and we should mention, jon, the report we're referring to was produced today by the department of health and human services. there's another medical story that we're followi
settled the lawsuit. in 2006, the fda issued a warning left for necc to stop marketing the cream. they produced thousands of doses of the steroid. >> when was the last time either the food and drug administration or the massachusetts board of pharmacy were visiting this business and looking carefully at what they were doing. we already know that they had had a history of problems, was anyone following up with that? >> reporter: this is by no means the first time safety concerns have been raised about these specialized compounding pharmacies. since 2004, the fda has issued 49 warning letters to compounding pharmacies around the country for significant safety violations. and at least 19 previous deaths may be associated with drugs from these pharmacies. the fda says it has some authority to regulate them, but that the agency's authority over compounding has been challenged vigorously in the courts by compounding pharmacies as well as in congress. but critics argue that because necc was manufacturing drugs on a wide scale, the fda clearly had authority to act. >> the fda for whateve
. >>> the fda issued a new warning about discount drugs. you can find several common medications online for less, but it may not be worth the risk, details coming up. check out the rundown. we're back. >> is in fox 5 news edge at 11:00. ♪ [ male announcer ] the first look...is only the beginning. ♪ ♪ introducing a stunning work of technology. ♪ introducing the entirely new lexus es. and the first ever es hybrid. this is the pursuit of perfection. >>> the fda is cracking down on fake online farms. a survey found 25 -- pharmacies. a survey found 25% of consumers have purchased prescription drugs online. 30% have doubts about the safety of those drugs. fox's brenda buttner has more. >> certain websites may be hazardous to your health, the fda cracking down on thousands of online pharmacies selling fake drugs and not just to folks like you and me, but to medical professionals as well. lisa gill is the prescription drugs editor for consumer reports. she says approximately 1.7 million people use online pharmacies, but the counterfeit drugs they could be selling carry a very big risk including
them last week to the departments of justice because they quoted fda saying something they never said, making it look like they were opposed to prop 37. they put at the's logo on it and said to voters. this is a group of companies that is desperate to do anything they can to convince the voters to vote against our right to know what is in our favor. it is having an effect in the polls, but i do believe when voters go to the voting booth on november 6 are going to buy our right to know what is in our food and vote yes on prop 37. >> final words, david zilberman, the issue of simply consumers having a right to know. maybe they won't know about everything from this legislation, but at the beginning, as you said, 70%. >> ok, so -- [indiscernible] need to establish some sort of known food, something that is basic, and everything else should have voluntary labeling. i think gm foods belong to the future of america agreedgm was invented at berkeley by scientists. basically they take something that belongs to the people, which is the genetic innovation, and make it something that belongs to t
by these medications made by this pharmacy. that's enough to trigger the warning from fda. >> woodruff: and the concern is other types of infections as well as meningitis, as i understand it. is that right? >> meningitis is the chief concern but it can cause infections in the joints and things like that. not a good idea. >> woodruff: but the connection, as i understand it, is not completely confirmed yet. they have the patients. they're concerned that there may be a link but they haven't been able to nail it down yet. >> right. fda is careful to say it's out of an abundance of caution. that's their language. here we have a potential meningitis case in a patient who had a drug from his pharmacy, but it's not enough, you know, you have to basically have the fungus in the patient or the meningitis in the patient and see the link directly to the medication they received. they haven't been able to do that yet. at this point this is a caution. >> woodruff: at this point we're just talking about two cases, two people. is that right? >> today. two people. that's aside from the, you know, 231 or so patients tha
are truthful and not misleading. the fda doesn't have the ability to look at the substantiation behind the claims, so there's no way for consumers to know if the claims are truthful. >> reporter: federal law classifies them as food, not drugs. products are required to be safe, but the fda only monitors them after they're on the market. when it comes to proof, supplement makers are only required to say research has been done. they are not required to show it to the fda. the natural products association issued a statement saying "this small sample of supplements shouldn't smear the entire industry." the investigators looked at 127 supplements claiming to help with weight loss. none met the fda's recommendations for proving the products work. >>> fleet week arrives in dramatic fashion. [ crowd noise ] >> a navy hover craft came ashore at ocean beach this morning. the 60's-ton l-cat can be used to deliver heavy equipment in a disaster. it plied a role in the days after hurricane katrina. events that will create grik this weekend. the america' >>> fleet week is just one of the events that w
that the pharmacists could make custom specific doses for patients with those needs. now the fda is not charged with regulating them, because the compound facilities are not making new drugs, just charged with mixing them. but i'll tell you over the last few years, compounding pharmacies have grown over the past few years, accounts for many of the drugs taken by patients over the last few years. it is big business, has little oversight and it impacts all of us. you work here? >> i'm security for the facility. >> reporter: okay. all week we have been trying to dig up anything to try to understand how a common steroid injection could have become so deadly. >> unfortunately, i have to ask you guys to leave the property. >> reporter: no one here really wants to talk. >> your call has been forwarded. the number you dialled is not in service. the call has been forwarded to an automatic voice message system. >> reporter: all right. hello, i'm trying to get ahold of barry cadden, that one? wrong number. is there somebody we can actually talk to? i even went straight to the home of barry cadden, the own
questions to whichhe extent these claims are truthful and not misleading. fda doesn't have the ability to look at the substantiation behind the claims. there's no way tore them or consumers to know whether or not the claims are truthful. >> reporter: the fda has only limited power to regulate supplements because federal law classifies them as food not drugs. when it comes to proof, supplement makers are only required to say research has been done. they are not required to show it to the fda. the natural products association, the main trade group of the supplement industry issued a statement saying this small sample of supplements shouldn't smear the entire industry. the investigators looked at 127 supplements claiming to boost the immune system or help with weight loss. none met all of the fda's recommendationses for proving the products actually worked. >>> a woman accused of riding a manatee has turned herself in. on sunday a bystander snapped a photo of the woman. after a statewide search, gutierrez surrendered on tuesday. she said she didn't know she broke the law. she could be cha
this. with 25 drugs in development and a major fda advisory panel meeting next week, cramer is examining a stock that could be the next big thing in biotech. stick around. you can't afford to miss his prognosis. >>> later, on to trot? all this week cramer is finding the stocks that the big money is most likely buying hand over fist, and should continue to rise until year end. tonight the temperature reaches a fever pitch. he adds two biotech bohemaths to his hot list. don't move. the big reveal and just ahead. plus, "mad money" at the movies. cramer has always had a certain theatrical flare, but tonight he shares the stage with an authentic star of the silver screen. warner brothers argo hits theaters this weekend and cramer is welcoming its baddest cast member in to talk business. you won't want to miss cramer and kremston on one screen. all coming up on "mad money". >> don't miss a second of "mad money". follow@jim cramer on twitter. have a question? tweet cramer. send jim an e-mail to "mad money"@cnbc.com or give us a call at 1-800-743-cnbc. miss something? head to "mad m
is regulated by a pharmacy, not the fda. its owners are not taking questions. dr. sanjay gupta got as far as the parking lot before he was told to leave. he managed to take a look behind the facility though. what he found was surprising. a recycling site filled with waste and garbage, right next to the building where inside medications are mixed. turned out the recycling center is owned by the same guy who owns the compounding center. today, sanjay did some more digging. this is what he found. >> necc, this is the place where the deadly meningitis outbreak started. we came here looking for answers. but we soon found out no one would talk. is there someone we can talk to? wove been leaving voice messages and -- >> i even went straight to the home of the owner of the facility. there was a car parked at the end of the driveway. no visitors allowed. but i was told they would call me back. they didn't. >> we're trying to get some information. but there was something else we noticed. >> look closely at the name of this garbage facility connected to the necc. conigliaro. this is the maiden name
blamess "monsser energy" for her daughter's death.paul gessler reports the f-d-a is noo to five other cases. casess "it's juss sometthng you neeer wanna go through."wwnny crrssland is coming up on the &pone- yeaa anniversary off wendy crossland, mother: "she was gasping for aar. she as maainn these awffl noises. she the loor and her heart had on stopped and starttd cpr..thh 14- year- old haaerrtown girl hospital, but later died.thee cause of death: cardiac arrhythmia due to affeine toxicity.hee mother says gimbel, ssbstance abuse - pducatoor"they can put waa &pone of theseecans in a ouple of minutes, so it becomes veryy ery dangerous. and, it's been that way for a while."drug czar mike gimbell urges warning labels or even age limits on energy drinks. mike gimbel, substtnce abuse paul gessler, reporter: kkds padvocates say the problemmhas grown over the yearss.. littrally. this is monster this is what anais drank--two of them, actually. jjst one energy driiks has the caffeine rrgulation: "ms. crossland f - wants to make sure that energy drinks are regulateddby make sure tha
cautious fda did not allowed to things. this occurred under the obama administration. the first thing that they did not allow for it adjuvants. an adjuvant is something that extends the vaccine supplied so it stimulates the immune response so you don't need as much vaccine if you had an adjuvant. this is not the controversial technology used in europe. it's used in europe but is not controversial technology. that was not allowed. secondly, at the last minute they ordered a switch from multi-dose to single dose vials. why? the reason is single dose vials have less thimerosal. thimerosal is the chemical which contains a little bit of mercury that the anti-vaccine crowd says causes autism. in 2009 this myth was thoroughly debunked and yet obama and the fda gave into that impartially as a result we had a vaccine shortage. what was the outcome of the 2009 h1n1 influenza? 61 million americans in that being infected and 274,000 hospitalizations and 12,470 deaths. i'm not a person who says barack obama killed all those people. i don't believe that. i don't believe the fda killed all those peo
their daughter's death which they believe was linked to a popular energy drink as the fda take a close are look at the other similar cases. fox 5 morning news continues right now. right now. and the family of a 14-year-old maryland girl sues over their daughter's death. >>> it feels like a little bit of summer in the air, i believe. i'm sarah simmons. >> i'm allison seymour in for wisdom martin today. so excite about the forecast. i'm going for bathe myself in 80 degrees today. >> you could do that. >> our temperature a good five to eight degrees warmer than yesterday. yesterday turned into a beautiful day. next couple of days, we'll keep the warm trend around here. >> i will take advantage of both days. >> turning the corner next week. things are going to change big time. let's get to the maps. nice start to your day. a few more clouds in the forecast than yesterday. not going to be a perfectly sunny day. we have rain pushing up into the great lakes and into western pennsylvania and ohio. some of that cloud cover will continue to spill into the area. it will be a partly sunny day in and out of
enforcement officials and so forth. .. at the u.s. fda, within the office of criminal investigations, oci. her job there as part of her jobs are not only making john roth look good, but also she handles an array of drug investigation, particularly those involving counterfeit medicines. aside from her current position here at washington headquarters she has also over the course of her past 13 years with fda served in both the washington and chicago field offices as well. next up we have linda marks. linda serves as senior litigation counsel at the consumer protection branch at the is department of justice. she is responsible their for internet pharmacy, for counterfeit pharmaceutical, for fda fraud and a host of other issues. linda has tried internet pharmaceutical cases and also heads the consumer protection branch of the counterfeit drug team at u.s. doj. and last but certainly not least we have gerald heddell. gerald choices from the uk's medicines and health care products and regulatory agency. there he serves as the agency's director of inspection enforcement and standards division. he foc
. but the difficulty is that john at the c.d.c. and the folks at the fda, they are able to respond after the fact, after people are sick or dying from these conditions. the fda today really doesn't have the right sort of authority from congress to regulate this type of compounding, this industrial compounding before the fact, before there's a problem. >> brown: that, of course, is the big question being raised now. who is guarding? who is watching against something like this happening? what is the regulatory regime? it begins with the states rather than at the federal level? >> it's a pharmacy. just like the c.v.s. or wall greens on your corner, it's regulated first by the state, by whatever state it happens to be in. the fda is in charge of regulating drugs and drug manufacturing. so if pfizer or glaks owe wants to produce a drug in china or ireland or anywhere else in the world and sell it in the united states, that factory is under fda regulation. very strict rules on how the... how sanitary it is, how careful they are preventing contamination. but a compounding pharmacy especially one that is
questions about the extent to which these claims are truthful and not misleading, because the fda doesn't have the ability to look at the substantiation behind the claims, so there's really no way for them or consumers to know whether or not the claims are truthful. >> reporter: the fda has only limited power to regulate supplements because federal law classifies them as food, not drugs. products are required to be safe but the fda only monitors them after they're on the market. when it comes to proof, supplement makers are only required to say research has been done. they're not required to show it to the fda. the natural products association, the main trade group of the supplement industry, issued a statement saying this small sample of supplements shouldn't smear the entire industry. the investigators looked at 127 supplements claiming to boost the immune system or help with weight loss. none met all of the fda's recommendations for proving the products actually worked. cbs news, new york. >>> now you might expect a shower to be one of the cleanest places in your home. as it turns ou
been reported and 15 people have died. dr. jon lapook has the latest. >> reporter: today's f.d.a. statement raises the possibility that other medications shipped by the new england compounding center-- n.e.c.c.-- were contaminated. wtil now, all the cases of meningitis have been linked to a single steroid called ngleylprednisolone. one patient treated with a back injection with a different steroid called triamcinolone has developed possible meningitis. two heart transplant patients who received another drug supplied by n.e.c.c. during surgery have developed an infection aspergillis, a fungus inked to the outbreak. it has not been disclosed reether these two patients have meningitis or something else. last week, the f.d.a. told doctors not to use any products distributed by n.e.c.c. today it went further saying doctors should now call patients who received any injectable product from the company after may 21. n.e.c.c.'s product list includes hundreds of injectable drugs, for everything from treating infections to cancer. the company told cbs news they te reviewing the f.d.a. state
kids to switch to red bull. it is a momentum stock. when you get a hint of the fda with a monster drink. you know what, i love this stuff. no, i think you got to be careful. i think you got to be out. >> al, in florida. >> we have miami beach, we haha miami. >> lots of volatility. what is up with that stock? >> where do you see disc drives al? they are in pc's. and people aren't using pc's. it is as shrinking market. >> mary? >> super value. i bought it at 303 and i watch your show all the time. i would like you to give me information at super value. at $303 would you hold it? >> i need you out of it tomorrow morning. you are playing with fire. the company you have all of these stories how they make you a tender offer. please, you are lucky that it is not lower. you need to have a $3, $4, $5 stock. may i suggest it is sprint. brutal day. but a lot of it has to do with managing expectations. the companies that blew up today didn't manage it well. it is how it always feels when the market is down this badly. later on this week. i bet you we put down a buy. >> coming up. lousy count? ppg's
are in the middle of the meningitis outbreak. and the end is not yet in sight. >> reporter: the fda revealed friday that federal inspectors who investigated the new england compounding facility found greenish black foreign matter and white filamentous material and supposedly sterile vials and residue in clean rooms or those used to mix medicines. the fda said the pharmacy's sampling repeatedly found bacteria and mold in supposedly sterile rooms between january and september 2012. yet no documented corrective actions were taken. an nacc spokesman said we will review this report and will continue our cooperation with the fda. >> the fact that this has been occurring, it seems like under the noses of the federal and state regulators is shocking. >> reporter: massachusetts regulators are under fire for rejecting a staff recommendation six years ago to reprimand the company and put it on probation after necc claimed that could put it out of business. the company was allowed to simply agree to change procedures. state officials say they are now reviewing the decision. the fda said its authority is limite
steroid for back pain was called in six years ago. >> reporter: fda was in this lab or pharmacy 2006 and they found they had a problem in 2006. that's six years ago. so where was the follow-up with respect to them. >> any change in your opinion? >> i think it does. we need better oversite. the law on the books just like anything, they're there. they just need enforcement. now, whether it's you need more manpower to enforce or whatever the case may be, more laws, i don't know, necessarily help if you don't enforce them. >> so exactly how this happened, that is what has gotten the questions going here. how did it happen. and here is the deal, derek, as far as how this pharmacy was shipping so much. the higher value pharmacies, they're the one under fda scrutiny. the smaller ones are under state farm see boards but there seems -- pharmacy boards but there seems to be a gray zone that needs to be addressed. >> so this pharmacy was shipping some thousands of doses all over the country. >> that's exactly. compounding companies were supposed to start out as mom and pop operations mixing up
Search Results 0 to 49 of about 1,000 (some duplicates have been removed)